MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	B35200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id b32000 lot# 082m35824 serial# implanted: (b)(6) 2025 explanted: (b)(6) 2026 product type accessory p product id b3300542m lot# serial# (b)(6) implanted: (b)(6) 2025 explanted: (b)(6) 2026 product type lead product id b3400060 lot# serial#(b)(6) implanted: (b)(6) 2025 explanted: (b)(6) 2026 product type extension product id b3400060m lot# serial# (b)(6) implanted: (b)(6) 2025 explanted: (b)(6) 2026 product type extension section d information references the main component of the system.Other relevant device(s) are: product id: b32000, serial/lot #: (b)(6), ubd: 23-dec-2026, udi#: (b)(4) ; product id: b3300542m, serial/lot #: (b)(6), ubd: 27-feb-2027, udi#: (b)(4) ; product id: b3400060, serial/lot #: (b)(6), ubd: 20-may-2027, udi#: (b)(64) ; product id: b3400060m, serial/lot #: (b)(6), ubd: 27-mar-2027, udi#: (b)(4).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that a patient with an implanted deep brain stimulation system experienced an infection that was reported as unrelated to any external factor.No diagnostics or troubleshooting were performed.Surgical intervention was performed, and all deep brain stimulation components were explanted at the patient¿s request to address the infection.The issue was reported as resolved at the time of the report, and the patient outcome was reported as alive with no injury.

• Brand Name: PERCEPT
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 25683884
• Report Number: 3004209178-2026-11096
• Device Sequence Number: 21260157
• Product Code: MHY
• UDI-Device Identifier: 00763000916268
• UDI-Public: (01)00763000916268(17)270314
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2026
• Supplement Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 07/01/2026
• Supplement Report FDA Received Date: 07/16/2026
• Date Device Manufactured: 03/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male